Vol. 52, No. 6, Special Issue 1992 379

What Do Consumers Want?

William Apple Assistant Editor Consumer Reports Magazine 101 Truman Avenue Yonkers, NY 10703-1 057

Abstract A consumers’ advocate discusses the needs of the

consumer in evaluating dental products. Although com- mending the roles of the FDA and ADA in evaluating products, numerous questions are raised and recommen- dations made concerning advertising claims.

Key Words: consumers, dental products, FDA, ADA, mouthrinses.

Whatever we cover at Consumer Reports, we give read- ers straight, honest advice to sort out the marketplace. We test and evaluate products, name brands, and tell it like it is, whether we’re talking about a vehicle that can ruin your day by rolling over or a mouthwash that says it fights plaque but does not. We have tested toothpastes for abrasiveness. We have even tested dental floss and can tell you the brands that are strongest and those most likely to fray. To stay objective and credible, we don’t take money or advertising or samples from companies. Our 5 million subscribers count on us.

Now, the task at hand: The US Food and Drug Admin- istration (FDA) is an important watchdog in which all Americans have a stake. Every year, the FDA regulates more than half a trillion dollars’ worth of foods, drugs, cosmetics, and medical devices, things that touch us every day. Its standards for over-the-counter dental products are rigorous and painstaking, as we‘ve heard here.

The American Dental Association (ADA) is a 132-year- old, respected professional group. Consumers know the ADA seal on toothpaste and, more recently, on mouth- wash. The seal is a pledge also backed by rigorous stan- dards, as we have heard. ADA-accepted toothpastes de- liver on their promise to fight cavities. ADA-accepted mouthwashes pack chemicals proven to fight plaque and gingivitis, and they deliver. Both the ADA and the FDA are important allies on the consumer‘s side. So what more could consumers want? What consumers want in toothpaste and mouthwash

isn’t so different from what they want in other areas. We want products that work toward giving us healthy teeth and gums, that don’t mislead with slick advertising or labeling, that don’t cost a fortune, and that are easy to use.

We don‘t want to be lied to or confused. But things are not so simple.

Why do people-your patients, say-use mouthwash? If you want mainly to ward off plaque and gingivitis,

you might pick Listerine, the best-selling mouthwash in the US, and it has the ADA seal. Then, again, you might choose the runner-up in sales, Scope, to vanquish bad breath. Ads say it ”kills on contact 90% of the bacteria that causes morning breath.” Fluorigard, a fluoride rinse, will help you fight tooth decay. But if tartar is a problem, there’s Colgate’s Tartar Control formula. Suppose you want all four benefits? Well, mix your own cocktail, but I cannot vouch for safety or effectiveness. The world of mouthwash has become pretty complicated. I am im- pressed by a product that kills 90 percent of bacteria, but I do not know what to make of that number or its import. There is no context. Likewise, many consumers-intelli- gent p e o p l e 4 0 not know ”plaque” from “tartar.” Plaque can lead to gum disease. Visible tartar, the kind antitartar products curb, just looks bad but does not generally harm gums. I might confuse Colgate’s benefit with Listerine’s. Labels and ads do not clarify things very much.

More label confusion: What is the difference between Regular Strength Aim and Extra-Strength Aim in the blue box? That box tells me that conventional fluoride tooth- pastes have 1,OOO ppm fluoride. It fails to tell me how much fluoride the extra-strength formula has-it’s 1,500 ppm, which I learned by calling the toll-free line. (It’s also printed on the tube, but you would have to open the box in the store to find out.) But who needs that much? Is 50 percent more fluoride better? Could I use it and brush less often?

Biotene mouthwash, and yet more confusion. The label says the formula “uses two antibacterial enzymes which boost the defense system normally found in your saliva ... (to) help protect your teeth and gums.” It does not give a clue about what the enzymes do or what they protect against. Biotene’s research director assures me that the enzymes really kill bacteria. But he would not go on record as saying Biotene is an antiplaque or anticaries rinse. The formula contains no alcohol, he added, so I need not worry about recent research linking certain alcohol-containing rinses and oral cancer. (I was not wor- ried-the findings are only tentative.) Biotene rinse can

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help people with dry mouths, he said. Now this could be a breakthrough product-I just do not know.

Where does the FDA come down? The FDA regulates labeling on toothpastes and mouthwashes, to keep man- ufacturers in line. From what Jeanne Rippere told us earlier, there might still be some snake oil on store shelves. The FDA reports that she mentioned-covering anti-cavity, oral-injury, and oral-discomfort products- found three-fourths of ingredients not safe and/or not effective, or that we do not know enough about the ingredients to say. Three-fourths.

Products that claim therapeutic value-like fighting cavities with fluoride or fighting plaque with special chemicals-must apply to the FDA as new drugs. Dr. Walters told us that the whole process can take a decade or more, as supporting data are collected and evaluated. Why do the wheels turn so slowly, and what are the consequences? Case in point, a headline from Advertising Age, a trade paper:

“FDA order halts P&G, Colgate toothpaste intros.” The gist: that two new toothpasteswith triclosan, an anti- bacterial that kills plaque germs-will be held up for maybe three years by FDA review. True, the FDA has to weigh safety and efficacy-Americans must be pro- tected. But can it not work faster? Triclosan toothpastes and mouthwashes are sold in Europe. Research shows that triclosan toothpastes cut plaque and gingivitis some 30 percent compared with regular toothpaste. Must Americans wait so long? Make no mistake: I want the FDA as a cop on the beat, but just wish the cop worked faster.

The FDA is now investigating antiplaque products already being sold. Some plaque-fighting claims, like those on many toothpastes, are hyperbolcthe denti- frices use no special ingredient, just the brushing action to cut plaque. The more interesting claims-and the products that offer something more than abrasion against plaqueare based on chemical agents.

Some companies, though, have stepped away from plaque claims they used to make: Cepacol, for example. Two years ago, the bottle read ”Antibacterial Plaque- fighting Formula.”

Now bottles carry other messages (for example, ”#1 in hospitals for oral hygiene”), and the general pitch is ”for a fresh, clean-feeling mouth, and daily oral hygiene,” a spokesman told me. Cepacol actually contains an agent known to fight plaque, cetylpyridinium chloride, but choosesnow not to tell that to consumers. Viadent tooth- paste and rinse also make antiplaque claims, based on another chemical, an extract of the bloodroot plant. Via- dent is sticking by its plaque-fighting claim and has research to defend it.

In comparing the FDA and ADA, I would give an edge to the ADA acceptance-seal program. That is because when the ADA grants its seal, it reviews not just labels, but a company’s advertising. Ads pull people into stores

and make their hands reach for one product over another. Sad to say, the FDA has no jurisdiction over advertising for over-the-counter toothpastes and mouthwashes- zilch. Checking on ads belongs to another government agency, the Federal Trade Commission, which has its own rules and standards and has not always agreed with the FDA. It makes me edgy that a product may say things in ads that it would not be allowed to print on a box or label. Strange, but that is how the system works.

Let me turn quickly to generics and mention two other enforcement groups also on the consumer’s side.

Generics are a mixed blessing-+ lot cheaper than brand-names, but are they really equivalent? Here, the ADA seal helps out. Here is a bottle of Listerine and a drugstore brand that looks and, to my mouth, tastes like the real thing. Both bottles have the ADA seal as plaque and gingivitis busters-both rely on alcohol and essential oils. The seal assures us that both do what they are supposed to. When ADA put its seal on private-label brands, it cleared up some confusion.

Here is Plax, the third biggest-selling mouthwash, and some of its knockoffs. The labeling and claims are pretty much the same all around. You rinse, and the solution is supposed to loosen the plaque; then you brush nor- mally-with toothpaste-and somehow more plaque will be removed from teeth then if you had just brushed but not prerinsed. Well, this is a case where even if the generics work as well as the big brand, none of them do the trick.

We ran this item on Plax two years ago in Consumer Reports. Then, Plax was claiming to “remove 300% more plaque than brushing alone.” We told our readers to brush off that claim. Mouthwash competitors had called in the Better Business Bureau’s National Advertising Di- vision, a group that’s a key arbiter of questionable claims. The BBB investigated Max’s research and found it want- ing. One of the manufacturer’s studies let people brush for only 15 seconds and denied them toothpaste. Under such strange circumstances, the product lives up to its 300 percent claim, but apparently not with more normal brushing.

Plax has taken the 300 percent claim off bottles. Now the label says only that Plax removes “more” plaque than brushing alone. Plax also expunged another contested claim, that ”special anti-bacterial ingredients kill the germs that cause plaque.”

Here, from my files, are some more recent studies with basically the same punch line: that Plax, when usxi with normal brushing, is no better than a placebo rinse. A paper this year from the American Academy of Peri- odsntology, summed up Plax this way: “A number of investigations have not been able to reproduce plaque- reduction results found in manufacturer-supported studies. In these studies, no effect on plaque redudion when compared to a placebo used in a similar manner has been found.”

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But the facts on Plax continue to play out. In February, Pfizer, Plax's owner, and its ad agency signed an agree- ment with the attorneys general of ten states to halt what was called "misleading advertising" and "unsubstanti- ated and deceptive health claims." According to a press release from the New York Attorney General: Pfizer and its agency had "misrepresented the effectiveness of Plax ... and implied that Plax is the only true means of remov- ing plaque from the mouth. Some of the ads, which were unsubstantiated, claimed that 'plaque is the Number One dental problem,' and that no one brushes well enough to remove sufficient plaque, even when using a tartar-con- trol toothpaste three times a day."

The legal agreement effectively bans Plax from saying it can be used to diagnose, cure, mitigate, treat, or prevent tooth or gum disease. Which does not leave much that Plax can say. Pfizer admitted no wrongdoing but signed on the dotted line and reimbursed the states $70,000 in legal costs.

The marketplace for dental products is more compli- cated than ever. It is not just one or two brands of tooth- paste out there anymore. Companies face competitive pressures they have never before faced, and temptations abound to move the merchandise by whatever appeals work. Dr. Bamett ticked off a number of those marketing tricks earlier, how companies' advertising plays fast and loose with research findings. So consumers need protec- tion now more than ever.

The attorneys general of individual states, the Better Business Bureau, the American Dental Association, and the Food and Drug Administration are all important watchdogs for us. So, too, are TV, newspapers, and mag- azines that cover health topics. The more eyes that are watching over the marketplace, the more likely labels and advertising will be kept honest.

Materials, Ads, and Ethics I do not have much to say on dental materials except

that consumers should pay more attention to them. The truth is most people know as little about what the dentist puts in their mouth as they do about microchips in their VCR or spark plugs in their car's engine.

The best figure I could dig up is that Americans spend more than$20 billion a year to restore or replace teeth lost or damaged by decay. $20 billion is 10 or 12 times what we spend on toothpaste and mouthwash and I do not think counts teeth lost to gum disease. With that much or more at stake, consumers should be guaranteed that they are getting the best materials-proven materials that will last, give good use, and that will not create problems of their own down the road.

We have heard that ADA people chair a key committee at the American National Standards Institute, whose work is in turn consulted by the FDA. That cooperation should be comforting-it has potential to help consumers get the best. I just do not know enough of the details to

S Y . Which materials dentists choose for a patient is a mat-

ter of professional judgment. That will depend not only on their training and continuing education, but on adver- tising and marketing to professionals-ads dentists see in journals, direct mail, and sales calls made by company reps.

But I am getting out of my depth on dental materials. I would like quickly to pick up some points from yester- day, things consumers might be concerned with. Maybe they will spark discussion, and at any rate the points should be made:

Comparative Advertising. People want to know not just what works, but what works best. If we are talking mouthwash, which brands vanquish the most plaque the longest? If we are talking brushes, are power tooth- brushes more effective than manual ones? (If not, then $60 or $100 spent on a fancy eleckic brush is a bad investment.) And among manual toothbrushes, are those with specially shaped handles or brush-heads the same as the old-fashioned kind? Consumer Reports makes its living by rating products and telling readers the winners from the losers. In advertising generally, more compa- nies are now comparing their brand to other b r a n d s and naming names.

So I was surprised to hear that when the ADA grants its acceptance seal on a toothpaste or mouthwash or a toothbrush it does not allow "claims on superiority for one product over another." Surely all products are not the same. Responsible information, from the ADA or cleared by the ADA, could help consumers sort out dif- ferences.

Complex Formulations. Toothpastes and mouth- washes are surely becoming more complicated chemi- cally, not simpler. That is unavoidable, as manufacturers compound products to do more and more for our teeth and gums. So what about putting expiration dates on packages? Shelf-life is not forever. The last time I looked, very few toothpastes had dates. And I do not think I have ever seen a mouthwash with one. Do ingredients go bad? How does fluoride age in a dentifrice? How can consum- ers know they are getting fresh products? When you buy aspirin, there is usually a date. Why is there none on these over-the-counter dental products?

OTC or by Prescription? At what point does the FDA let a prescription product become an over-thecounter one? Let us take Peridex, Procter & Gamble's antiplaque rinse with chlorhexidine. It has been on sale by prescrip- tion in the US since 1986. And the active ingredient, a broad-spectrum antimicrobial, has been around for 40 years. (Surgeons have used chlorhexidine for scrubbing, I am told.) In Europe, chlorhexidine has been used in over-the-counter toothpastes and mouthwashes for years. The chemical is a heavy-hitting plaque-fighter that might benefit many more people than those currently using it. Its price might plummet, too, if it went over the

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counter. So how bng does it take to bring out OTC Peridex or other hands with chlorhexidine-and what is delaying it? A Fkxible Seal? The ADA plaqw-fighter seal on

mouthwash is great. It is backed by solid research and helps cmsumers find rims that actually work against plaque and gingivitis. Will the seal ever be extended to a toothpaste-and-mouthwash system, a pair of products marketed together and designed to be used together in a regimen to combat plaque? My query is not hypotheti- cal-I am thinking about Viadent toothpaste and rinse.

Is the ADA seal flexible enough to cover such an instance, assuming the pair of products when used together can meet the ADA's criteria?

I also raised a hypothetical ethics issue, based on a rumor I had heard-that the ADA had turned down an ad for an OTC product in its journal, apparently because the product did not meet ADA's advertising and claim- substantiation standards. What would the ADA do if it saw the same ad running elsewhere? Would it tell its members?